Working at the interface of computation, engineering, and biology, AbCellera is redefining the process of how drugs are discovered. We’ve developed an AI-powered technology stack to discover antibodies and deliver large pools of curated candidates to our partners. And, we’re not stopping there. With nearly 300 AbCellerites and growing, we’re expanding our capabilities to include internal CMC development and GMP manufacturing of antibodies to bring therapies from idea to patients, faster.
The Vice President of Quality will be responsible for building a team and designing facilities to meet an audacious goal: to go from discovery to fill-finish in a year. You will be given the freedom to innovate and move at lightning speed to create a legacy in our industry.
We’re offering a generous compensation package including an equity stake in AbCellera’s success. Our future facility will be nestled in the heart of Vancouver, Canada - we’ll support you and your family in every way we can to relocate if you haven't had the joy of living in this beautiful area!
You will be a key senior leader responsible for the design, construction, qualification, and operation of a new GMP manufacturing facility for the production of antibody therapeutics. The facility will produce API for global clinical studies and will be based around 2x2000 L single use bioreactors. This person will be responsible for establishing the quality policies, practices, procedures, standards, and systems necessary to ensure the facility and all products produced within it are manufactured, tested, and released in compliance with GMP regulations/guidance. You will establish and oversee the QA and QC departments at the facility and will be a key leader at AbCellera responsible for delivering on a critical strategic program that will have a long-lasting legacy on the organization and Canada.
How you might spend your days:
As the senior leader in the establishment of the Quality Department for the new GMP Manufacturing facility and operation. This includes:
- Providing exceptional leadership to the organization, including hiring, mentoring, and developing staff
- Serving as the senior Quality leader for the design, construction, and start-up of a new GMP Manufacturing facility for the production of antibody therapeutics. This includes:
- Serving on the project team as the senior Quality leader responsible for all aspects of QA and QC, including providing oversight of facility and equipment qualification
- Working with AbCellera leaders to ensure facility design will meet all strategic requirements related to capabilities, scale, capacity, cost, and timeline
- Ensuring facility is designed for the future, including the ability to implement innovative manufacturing approaches, add additional capacity, and/or extend into other competency areas (e.g., drug product manufacturing)
- Hiring and leading the QA and QC leaders who be responsible for all aspects of facility design, construction, qualification, and start-up of the new facility
- Critically, leading the development and implementation of all GMP systems with an emphasis on paperless eSystems. Ensuring all compliance documents, procedures, and processes are properly identified, drafted, and approved
- Championing the development of all necessary quality plans, risk assessments, strategy documents, and regulatory assessments
- Successfully bringing the facility online for GMP manufacturing operations
- Being overall responsible for all aspects of site operation once the facility is online. This includes:
- Hiring, leading and mentoring exceptional QA and QC teams to support the manufacturing facility. This includes working to establish a powerful culture that is integrated with AbCellera’s operations
- Playing a critical leadership role in the development of a risk-based, Quality paradigm for AbCellera’s GMP operations; this role is responsible for developing and establishing all aspects of a robust Quality infrastructure in the Manufacturing operation
- Ensuring all aspects of the operation are aligned with regulatory guidance/policies/expectations from global regulatory agencies, including Health Canada, FDA, and EMA
- Providing senior leadership to ensure the facility and operation is prepared for all quality audits by AbCellera partners
- Serving as key leadership for interactions with regulatory agencies, including ensuring the facility and team are prepared for regulatory inspections by global regulatory agencies and that any findings are addressed promptly
- Supporting CMC sections of regulatory filings
- Being responsible for all aspects of lot review and disposition
- Promoting a progressive culture of World Class GMP Manufacturing Operations
- Budgeting and planning, including:
- Playing critical leadership role for the development of long-term strategic site plan
- Working closely with AbCellera Business Development team to support establishment of global partnerships for antibody discovery-through-GMP
- Establishing and effectively manage operating site operating budgets
We’d like to hear from you if you have:
- 12+ years of experience in manufacturing of biologics in a GMP setting
- 10+ years of experience in a senior leadership role managing Quality operations within a biologics GMP manufacturing operation
- Outstanding technical acumen, operational understanding, and GMP compliance in building and managing the Quality Department
- Strong leadership passion to build, lead, and mentor a team with the opportunity to leave a lasting legacy on the team, the organization, and the country
- A desire to innovate and push to do things differently
- Strong knowledge of GMP systems and GMP manufacturing operations
- Demonstrated strong communication, teamwork and relationship building skills with stakeholders across the organization
- The ability to apply pragmatic, risk-based decision making to the operation
- Strong ability to be strategic, yet hands-on and detail oriented
- Experience leading a site through Quality audits and/or regulatory inspections
- Experience with CMC regulatory filings
- A BS/MS/PhD in relevant Science or Engineering discipline. A graduate degree preferred.
At AbCellera, we’re solving tough problems and creating innovative solutions from the ground up - custom immunizations, microfluidics, high-throughput imaging, genomics, computation, machine learning and laboratory automation - revolutionizing how our scientists can mine natural immune systems to discover new antibody therapies, and the scale at which they can do it. This is life-changing research and you could be a part of it.
You’ll join a diverse team of scientists, engineers, software developers, data scientists and business professionals - all working together to bring better therapies to patients. Last year, AbCellera was named to Fierce Biotech’s Fierce 15 list, and received three Fast Company awards, including the Most Innovative Team of the Year for 2020 and Best Workplace for Innovators.
We’re a growing company with a high-throughput tech stack and the drive to be the best in the industry. This isn’t just about having the best technology, it’s also about having efficient and seamless operations based on teamwork and cutting-edge tools. We know we need a world-class team of visionaries and innovators across the entire organization. We look for people with drive and energy. Idealists. People we love and people we trust. This may be unconventional, but it is the key to our success. We’re looking for someone like you to support, nurture, and organize our efforts along the way.
AbCellera is a technology company that searches, decodes, and analyzes natural immune systems to find antibodies that its partners can develop into drugs to prevent and treat disease. AbCellera partners with drug developers of all sizes, from large pharmaceutical to small biotechnology companies, empowering them to move quickly, reduce costs, and tackle the toughest problems in drug development.